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510(k) Data Aggregation

    K Number
    K142206
    Device Name
    Dental Unit
    Manufacturer
    Zhuhai Siger Medical Equipment Co., Ltd
    Date Cleared
    2015-03-13

    (214 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhuhai Siger Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Unit is intended to supply power to and serve as a base for dental devices; and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
    Device Description
    The proposed devices Dental Unit are well equipped dental unit, which are intended to supply power to and serve as a base for dental devices and accessories. They are intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. The products are attached with dental chair. The proposed devices include two models. U300 and U500. Both of the two models mainly consist of instruments, instrument arm tray, cabinet group, operation light arm, assistant position, pedal switch, and patient chair.
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